Lobbyists roll up sleeves for compounding battle

Both the House and the Senate bills are proposing new FDA oversight. | iStock photo

The two bills would limit the amount of compounded drugs a pharmacy can trade across state lines without being subject to FDA regulation.

The main difference is that the Senate bill, sponsored by Sen. Tom Harkin (D-Iowa), would give the most authority to the FDA — it would apply to all compounds traded across state lines. In the House version, by Rep. Morgan Griffith (R-Va.), FDA regulation would kick in only when compounding is a big portion of a pharmacy’s business — when more than 5 percent of its total output is compounds traded across state lines.

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At stake for the pharmaceutical companies, who are lobbying for broader FDA oversight, is what they see as the integrity of the FDA approval process. Companies hiring up lobbyists to work on the issue say they feel strongly about possible safety risks involved with unregulated drugs.

“The current debate has increased awareness of some of the dangerous practices that compounding facilities like NECC have been conducting for years without appropriate federal oversight,” Auxilium Pharmaceuticals spokeswoman Nichol Ochsner said in a statement.

Audrey Wu, a spokeswoman for KV Pharmaceutical, warned that “the practice of traditional drug compounding has evolved to a large-scale industry of drug manufacturing without FDA evaluation for efficacy, safety and manufacturing quality.”

The example that comes up most often is the FDA’s decision in 2011 to allow the continued sale of a compounded version of Makena, a medication that reduces the risks of premature births. That drug was approved by the FDA, but the agency still allowed the compounders to sell the cheaper, copied version.

That incident has alarmed the pharmaceutical companies, and they’re worried that Congress won’t go far enough to stop compounders from making copy drugs without FDA approval. In a letter to the House bill’s sponsors, the GPhA and the Biotechnology Industry Organization warned that the current bill allows compounders to copy approved drugs, “thus potentially denigrating FDA’s established approval pathways as well as incentives for innovation.”

Also joining the fight to increase FDA oversight is a group of pharmaceutical and medical companies called the Working Group on Pharmaceutical Safety, whose members include Auxilium and KV Pharmaceutical. Its leadership includes former Health and Human Services Secretary Tommy Thompson, the chairman of TherapeuticsMD, and public health expert Sarah Sellers, an outspoken critic of compounding who has served as a member of FDA’s advisory committee on compounding.

The Working Group takes an even stronger stance against compounds, investing in lobbying efforts to prohibit compounds that copy commercial products. Spokesman Paul Lindsay said the group’s influence work has also included limiting patient exposure to “mass manufacturing under the guise of pharmacy compounding.”

“We’ve had productive meetings on the Hill and are encouraged by the work of the House and Senate towards a meaningful legislative agreement to provide appropriate oversight of pharmacy compounding,” Lindsey said.